The Society of Homeopaths Intend to Ignore the Law.

As we saw a few days ago, the medicines regulator have written a robust response to the current panic campaign by homeopaths to try to create new legislation that would let them practice legally. It is slowly dawning on homeopaths that their business model is illegal. And with current plans to simplify medicines legislation, that illegality has been exposed.

The Society of Homeopaths look like they have been lobbying ministers. An email to their members is reproduced below. They wanted to keep their lobbying activities private, but homeopaths are not good on detail and their letter has entered the public domain.

The letter is astonishing. The implication is that they know that their members are acting illegally but that they have got away with it for decades. They have sought reassurances from government ministers that current ‘levels of enforcement’ will be maintained. That is, they hope they can keep on getting away with it.

Best you read the letter.

Society meets ministerial team

Dear XXXXXXX,

Thank you for your continued support with the consolidation and review of the medicines act 1968 MP Letter writing campaign.

As you know, the Society and partners have been working extremely hard behind the scenes to represent members and their best interests in this matter, including taking a leading role on engagement with the Government.

On Wednesday of this week the current campaign resulted in a meeting between our representatives and the Ministerial team from the Department of Health.

The good news is that the Department of Health continues to be in favour of patient choice and access to homeopathy as it currently stands and recognises the potential impact to patients, practitioners and homeopathic pharmacies of any changes to the way the Act is enforced.

Although during the meeting it was discussed that Section 10 would not be part of the consolidation process it was highlighted that current levels of enforcement of the act would continue in the way it has done for the past 40 years and therefore would not seek to restrict the current homeopathic provision/access routes.

To amend Section 10 it would require a unique consultation process and could therefore not form part of the consolidation process.

The Society, together with partners will continue to engage with the relevant Ministers. When the review has continued through the legislative process the Minister has offered to meet with us again to review the situation.

Nearly every MP has now been contacted and I would like to thank those members that have written to and in some cases visited their MPs to highlight the relevant issues.

Parliament is due to recess on the 17th July and we will keep you fully abreast of the situation and let you know of any further action and next steps needed in due course.

In the interim thank you for your continued support

Best regards

Phil Edmonds

Chairman

Society of Homeopaths

Please note this email is intended for Society Members only and we would kindly ask for this email not to be re-produced.

The Society of Homeopaths have a code of ethics that is quite clear,

Registered and student clinical members are required to comply with the criminal and relevant civil law of the country, state or territory where they are practising.

It would appear that the Society intend to ignore the central illegality at the heart of their business. That they do not care about their code of ethics, should not surprise readers of this blog. That they sought assurances from government ministers that they could continue to hope that the law will not be enforced is quite astonishing.

Now, being the Society of Homeopaths, we should treat what they say with some skepticism. Freedom of Information requests may expose a different side to this story. We shall see. The wording here is ambiguous. Of course, there will still be legal access to some homeopathic products, and indeed there is no attempt by the government to choke this off. But that does mean they now have a free ticket to continue trading in the huge numbers of unregistered products on the market.

So, does this mean that Homeopaths need not fear the law?

I doubt it. Their campaign has had the effect of making it very public that the marketing of unregistered homeopathic products is illegal, that the practice is widespread, that homeopaths know this, and they intend to do nothing about it.

Regulators have an obligation to enforce the law. They have no choice in the matter. The MHRA have forced homeopathic pharmacies to withdraw products before. It is difficult to imagine they will not continue to do so.

In addition, the homeopathic pharmacies will also come under the regulatory eye of the General Pharmaceutical Council. Action at this level could quickly choke of illegal supply.

Homeopaths are not out of the woods. Hoping that they can get away with it is not a solution.

Their only hope is if the regulators themselves fail to uphold their duties. That is not impossible, but a very long shot.

I dont support UKIP but I must point something out. See 15.4http://www.ukip.org/media/policies/UKIPhealth.pdf
There are loads of votes associated with homeopathy hence the number of MPs seemingly getting in on this. Something will probably be sorted to keep the punters happy.
My solution would be a special non medicine catergory then everyone is happy- even maybe the duck?

The Greens are now a clearly pro-science party. We see human knowledge and scientific research as a good in, and of, itself, and as part of the solution to our problems, and the Green Party has explicitly embraced the Haldane principle.

And:

Over the last three conferences, we’ve changed party policy that stated homeopathy would not have to comply with the same kinds of regulations and testing that other products that claimed to have medical benefits did.

It is worth pointing out that the MHRA is an “executive agency”. Whilst the MHRA is accountable to the Department of Health (DH), considerable power has been devolved from Ministers to the management of the MHRA. The DH is not responsible for the day to day running of the MHRA. It is also worth pointing out that the MHRA is entirely self-funding. Although it receives some money from the Treasury, it generates a surplus which goes back to the Treasury. It costs the tax payer nothing.

The idea that the DH would instruct the MHRA not to enforce regulations is a curious one. It has all sorts of nasty political implications and would send out the message that fringe groups can successfully lobby the DH to get their own way. It would mean the end of the MHRA as an executive agency.

Oh, and not just fringe groups. Dare I whisper that it would open the door further to Big Pharma lobbying?

The SoH and their fellow travellers miss the point every time. Dogma blinds them.

Homeopathic blogs state that Section 15 (3) of the 1968 Medicnes Actis still in force and therefore the minister can change section 10. Beyond me.
The appropriate Ministers may by order provide that any of the provisions of sections 9 to 14 of this Act specified in the order shall cease to have effect, or shall have effect subject to such exceptions or modifications as may be so specified.

Section 10 of the Medicines Act is about special exemptions. What homeopaths tend to ignore is the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 as amended by the Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 2005? In particular, Schedule 6. And EU Directives.

A more sophisticated understanding of ministerial powers over-riding legislation is that it allows for emergency provisions. It’s not on a whim.

It’s like asking for war-powers because some kids vandalised your allotment.

The 1994 and 2005 acts that you quote refer to marketed products. These unlicensed medicines supplied from a pharmacy to a member of the public for an unsolicited order are not marketed. Therefore supply is at present under the remit of the GPhC.
I assume therefore that you are referring to unlicensed homeopathic medicines supplied by homeopaths to patients.

I am more certain with talking about licensed products than with unlicensed products. However you can consider the following if you like and pick holes in my analysis- I do find it all farcial but rather interesting.
We know that Nelsons registered click pill pack of Arnica 30th C potency is marketed. The finished product exists ie in retail, online and in price lists. It has been industrialy manufactured in batches.

No finished product exists for Arnica 10000th C potency or most others like Dolphin Sonar 30th anywhere in the UK.
You cannot buy them retail and they do not appear on any lists as finished products eg 10g of pills Dolphin Sonar 30C does not exist as a marketed product.Dolphin Sonar exists only as a list somewhere on a data base in a pharmacy. An unsolicited request comes in from a member of the public who choses the size, form and potency (or is advised). The 10g pills Dolphin Sonar 30th C is then ‘manufactured?’ as a single extemperaneous item as a pharmacy nostrum.
Therefore 10g pills Dolphin Sonar 30th C is not marketed. This is how the homeopaths see it – reading between the lines. This is more complex than just a straight forward matter of routine MHRA enforcement. The General Pharmacy Council control this.

As far as I can see non of these unlicensed products are listed on the web- only names. The form, potency and size are selected as part of the unsolicited order.You may be right but this justification will have to be considered on a risk benefit public safety viewpoint. Where there is considered to be a justified risk then there will obviously be restrictions. This is surely a grey area.
It may not be a walk in the park for either you or the homeopaths. Your evenings wont be free for some time yet.

Below is text from the MHRA draft guidelines Homeopathy advertising March 2011. This is quoted on homeopathic sites and applies to pharmacies. Note how it refers to homeopathic ingredients and not products. Dolphin Sonar apart- Are you sure the homeopaths are all as daft as you think they are?

All these requirements apply equally to advertising on the internet. A factual list of homeopathic ingredients and prices may be provided such as an A-Z list of ingredients and potencies available. The list must not link to any product claims since this is likely to be seen as making claims for and promoting the products. Information and links on the home page should refer to the service being offered and not to products.

“These restrictions apply equally to advertising on the internet. Product information, including sales material and any online purchase facility, may only be provided for licensed products.”

And the business of the simple list is tricky. That part of the guidance contradicts guidance for manufacturers and wholesale dealings with regard to unlicensed medicines and also the law. But as we are talking about online purchase facilities…

The text Malleus quotes (see below) refers to homeopaths and their websites. This does not apply to purchase facilities on pharmacy websites. It is not nailed Andy for supply of these unlicensed homeopathics to the general public. Maybe for supply to homeopaths who dispense these homeopathics- Is that what you mean?

These restrictions apply equally to advertising on the internet. Product information, including sales material and any online purchase facility, may only be provided for licensed products.”

1. Any person who, in breach of these Regulations, places a homoeopathic medicinal product on the market without holding a certificate of registration in respect of that product, or otherwise than in accordance with the terms of such a certificate, shall be guilty of an offence.

2. Any person who, in the course of a business carried on by him, sells, supplies, manufactures or assembles, or procures the sale, supply, manufacture or assembly of, a homoeopathic medicinal product, or who has in his possession a homoeopathic medicinal product, knowing or having reasonable cause to believe that the product was or is intended to be placed on the market contrary to paragraph 1 shall be guilty of an offence.

See my posts above. It is not that clear cut that pharmacy supply of these unlicensed homeopaths to the general public will be stopped and the pharmcies subject to legal action. Other opportunities will come your way for sure but this main supply route will be secure so long as the GPhC continue to allow their members to dispense homeopathics.

So what the regulations seem to try to restrict is the labelling of sugar pills as “homeopathic pills”.

That should not be a problem. Everyone has been told they contain no active principle. Calling them “homeopathic” is just advertising. And it’s honest and truthful because homeopaths have told us the dilutions are 30C (if not more) and therefore contain no active principle.

There’s no problem with having perfume sold as “Opium”. That contains no opium. (does it?)

Numerous other examples.

So why is the MHRA trying to restrict thought. They don’t prevent anyone selling a Bible or Koran (there is no evidence anyone has ever achieved salvation thereby)- why is a packet of ‘nothing except sugar’ any different?

So, would “Homeopathic remedy” be acceptable? Could they not sell “Arnica 30C – This product is a sugar pill prepared in accordance with homeopathic principles for patients who believe sugar pills labelled ‘Arnica 30C’ might help them”?

That would be fair, honest and truthful. And I bet sales would hardly be dented.

What we are actually seeing here is homeopathic manufacturers hoist by their own petard.

Catch 10 to power 23. Be honest and sales will go down (but not to zero, I’ll be bound). Be dishonest and there will be no sales at all!

So, would “Homeopathic remedy” be acceptable? Could they not sell “Arnica 30C – This product is a sugar pill prepared in accordance with homeopathic principles for patients who believe sugar pills labelled ‘Arnica 30C’ might help them”?

That would still appear to be marketing it as medicine.

Perhaps if they were to include a “for entertainment only” disclaimer like the ones that psychics used to use to get around the Fraudulent Mediums Act…

The issue is the “homeopathic” bit. Potentised remedy or vibronic essence or some other baroque wording would do.

Proving that a substance was prepared using a homeopathic method would be impossible. But the most difficult part is that if they are not homeopathic medicines, they would need to show their ingredients. Um. Sugar. And that’s it.

“Mr. Chairman, as Financial Director, may I ask why we are spending money on “homeopathic preparation” methods when the result is a sugar pill with no active ingredient. We could save a lot (and thereby increase profits) if we left all that out and simply made a, well, sugar pill.”

“Good point – what does the Production Manager say?”

“That would be easier and more efficient.”

“And Marketing?”

“As before Mr. Chairman. Folks are not buying any Arnica or Whatever, they are buying an ideation, a placebo. Folks should be able to buy what they want. We explain how we prepare the remedies and it’s perfectly obvious they are just sugar pills. If folks want to believe that they will help them, well and good.”

“Isn’t that unethical?”

“We explain what we sell- “Homeopathic remedies”. Everyone knows the score. Mr. Quack is always telling them! And how is any one ever, ever, going to know that the sugar pill has NOT been prepared ‘in accordance with the homeopathic tradition’?”

“Good point. That’s settled then. Next business- the purchase of a yacht in the South of France…”

Well, the manufacturers have regular inspections to ensure they abide by GMP. They have manufacturer’s licences. Strange as it may seem, they are subject to the same type of inspections as pharmaceutical manufacturers.